About this job

Quality Assurance Employee (m/f/d)

Creating and reviewing quality management (QM) SOPs
Review and management of all QM documents, including audit reports, training materials/certificates, qualification/validation documents, and manufacturing instructions.
Planning and conducting training courses
Processing/participation in/of quality assurance instruments (e.g. complaints, CAPA, deviations, risk analyses, self-inspections, etc.)
Tracking and monitoring of quality assurance instruments (e.g. complaints, CAPA, deviations, risk analyses, etc.)
Communication interface and contact person for quality assurance issues, including those related to manufacturing and quality control.
Processing and taking over independent internal projects for the development of new processes and process optimization

Pharmaceutical training or comparable education
High quality standards and awareness
Good knowledge of current EU and FDA GMP regulations, AMWHV and AMG
Enjoyment of independent, structured work as well as good communication and organizational skills
Good knowledge of MS Office
Excellent German skills, both spoken and written.
Professional experience in the following areas is an advantage: pharmaceutical industry, pharmaceutical production, quality management or comparable industries.

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Responsibilities

Quality Assurance Employee (m/f/d)

Creating and reviewing quality management (QM) SOPs
Review and management of all QM documents, including audit reports, training materials/certificates, qualification/validation documents, and manufacturing instructions.
Planning and conducting training courses
Processing/participation in/of quality assurance instruments (e.g. complaints, CAPA, deviations, risk analyses, self-inspections, etc.)
Tracking and monitoring of quality assurance instruments (e.g. complaints, CAPA, deviations, risk analyses, etc.)
Communication interface and contact person for quality assurance issues, including those related to manufacturing and quality control.
Processing and taking over independent internal projects for the development of new processes and process optimization

Pharmaceutical training or comparable education
High quality standards and awareness
Good knowledge of current EU and FDA GMP regulations, AMWHV and AMG
Enjoyment of independent, structured work as well as good communication and organizational skills
Good knowledge of MS Office
Excellent German skills, both spoken and written.
Professional experience in the following areas is an advantage: pharmaceutical industry, pharmaceutical production, quality management or comparable industries.